Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 35 of 439 for:    colon cancer AND Capecitabine AND colon cancer

Bevacizumab Plus Capecitabine (Xeloda) in Patients With Untreated Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00203411
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : February 6, 2017
Last Update Posted : February 6, 2017
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Translational Oncology Research International

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Drug: Capecitabine (Xeloda)
Drug: Bevacizumab
Enrollment 45
Recruitment Details Dates of recruitment period: October 2005 to February 2009 Types of location: Academic medical oncology clinical and community medical oncology clinics
Pre-assignment Details  
Arm/Group Title Bevacizumab Plus Capecitabine
Hide Arm/Group Description

Bevacizumab 7.5 mg/kg every 3 weeks will be administered interavenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.

Capecitabine (Xeloda): 1000mg/m2 administered orally twice daily for two weeks followed by one week rest period

Bevacizumab: 7.5 mg/kg IV will be administered every 3 weeks

Period Title: Treatment Period
Started 45
Completed 45
Not Completed 0
Period Title: Follow-up
Started 45
Completed 41
Not Completed 4
Reason Not Completed
Progressive Disease             4
Arm/Group Title Bevacizumab Plus Capecitabine
Hide Arm/Group Description Bevacizumab 7.5 mg/kg every 3 weeks will be administered interavenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
Overall Number of Baseline Participants 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 45 participants
79
(54 to 93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Female
27
  60.0%
Male
18
  40.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
American Indian or Alaska Native
0
   0.0%
Asian
4
   8.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
   6.7%
White
36
  80.0%
More than one race
0
   0.0%
Unknown or Not Reported
2
   4.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants
45
Eastern Cooperative Oncology Group (ECOG)   [1] 
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 45 participants
Score of 1 17
Score of 2 28
[1]
Measure Description:

ECOG Grade Evaluated by Physical Exam 0 Fully active, able to carry on all predisease activities with restriction

  1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature
  2. Ambulatory and capable of all self-care but unable to carry out any work activities. Out of bed > 50%
  3. Capable of only limited self-care, confined to bed or chair > 50% waking hours
  4. Completely disabled, cannot carry on any self-care, totally confined to bed or chair
1.Primary Outcome
Title Time to Disease Progression
Hide Description Progression Free Survival (PFS)- the interval from the date of enrollment to the first documented date of disease progression, death due to cancer, or the last date of a definitive assessment (not an unknown assessment) at which the patient is known to be progression-free. If there is an unknown assessment, then (a) if the next subsequent definitive assessment is complete response (CR), partial response (PR), or stable disease (SD), the patient is considered to be progression-free at the date of the subsequent definitive assessment and PFS is calculated as above; (b) if the next subsequent definitive assessment is progressive disease (PD), the patient is considered to be a failure at the time of the (earliest) assessment of unknown preceding the documented disease progression (i.e. PFS is back-dated to the date of the unknown assessment) and (c) if there is no subsequent definitive assessment, PFS for the patient is considered to be a censored observation at the date
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bevacizumab Plus Capecitabine
Hide Arm/Group Description:
Bevacizumab 7.5 mg/kg every 3 weeks will be administered intravenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
Overall Number of Participants Analyzed 45
Median (95% Confidence Interval)
Unit of Measure: months
6.87
(5.1 to 11.5)
2.Primary Outcome
Title Number of Subjects Requiring Dose Modifications
Hide Description Number of Subjects that required Bevacizumab or Capecitabine dose modifications, delay, reduction or discontinuation due to adverse reactions.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
all subjects that received chemotherapy
Arm/Group Title Bevacizumab Plus Capecitabine
Hide Arm/Group Description:
Bevacizumab 7.5 mg/kg every 3 weeks will be administered intravenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: participants
Delay in Bevacizumab Dose 15
Discontinuation of Bevacizumab 14
Delay in Capec itabineDose 8
Reduction of Capecitabine Dose 13
Discontinuation of Capecitabine 16
3.Secondary Outcome
Title Response Rates
Hide Description Evaluation of target lesions Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Time Frame every 21 days up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bevacizumab Plus Capecitabine
Hide Arm/Group Description:
Bevacizumab 7.5 mg/kg every 3 weeks will be administered intravenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: participants
Complete Response 2
Partial Response 14
Stable Disease 16
Progression 9
Not Evaluable 4
4.Secondary Outcome
Title Quality of Life of Patients
Hide Description

Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Trial Outcome Index (TOI) – a questionnaire assessing quality of life concerns pertinent to colorectal cancer patients. Questions address Physical, Emotional and Functional Well-Being. Scale: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), and very much (4). Higher numbers indicate a better state of well being. Scale 0 -136. Higher numbers indicating a better state of well-being.

The Overall scores for the FACT-C Composite scale range between 0-100 with higher scores indicating a better state of well being.

The EQ VAS= Euro Quality of Life 5 Dimension Self Reported Healthstate. It records the respondent’s self-rated health on a vertical, visual analogue scale where the endpoints are labeled 0 ‘Best imaginable health state’ and 100 ‘Worst imaginable health state’.

Time Frame Baseline, Cycle 2, and End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bevacizumab Plus Capecitabine
Hide Arm/Group Description:
Bevacizumab 7.5 mg/kg every 3 weeks will be administered intravenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline FACT-C Trial outcome index (TOI) 62.85  (12.12)
Cycle 2 FACT-C TOI 66.31  (10.32)
End of Study FACT-C TOI 62.09  (12.12)
Baseline FACT-C Composite 99.87  (19.87)
Cycle 2 FACT-C Composite 105.38  (17.02)
End of Study FACT-Composite 98.61  (21.73)
Baseline EQ-5D VAS 61.76  (23.17)
Cycle 2 EQ-5D VAS 68.59  (22.26)
End of Study EQ-5D VAS 66.54  (23.18)
Time Frame From time of consent evaluated every 21 days until 30 days after last treatment, up to 1 year.
Adverse Event Reporting Description Systemic adverse event assessment occurred every through investigator assessment during the Treatment period
 
Arm/Group Title Bevacizumab Plus Capecitabine
Hide Arm/Group Description Bevacizumab 7.5 mg/kg every 3 weeks will be administered intravenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
All-Cause Mortality
Bevacizumab Plus Capecitabine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Bevacizumab Plus Capecitabine
Affected / at Risk (%) # Events
Total   45/45 (100.00%)    
Blood and lymphatic system disorders   
Leukopenia  1  1/45 (2.22%)  1
Dyspepsia  1  1/45 (2.22%)  1
Gastrointestinal disorders   
Diarrhea  1  8/45 (17.78%)  8
Dehydration  1  4/45 (8.89%)  4
Vomiting  1  3/45 (6.67%)  3
Nausea  1  2/45 (4.44%)  2
Mucositis  1  2/45 (4.44%)  2
Anorexia  1  2/45 (4.44%)  2
Bloating  1  2/45 (4.44%)  2
Hemorrhage-GI  1  1/45 (2.22%)  1
Obstruction  1  2/45 (4.44%)  2
Infarction  1  1/45 (2.22%)  1
General disorders   
Fatigue  1  6/45 (13.33%)  6
Pain-Abdomen  1  2/45 (4.44%)  2
Hepatobiliary disorders   
Liver Failure  1  1/45 (2.22%)  1
Renal Failure  1  1/45 (2.22%)  1
Nervous system disorders   
Cerebral vascular accident  1  1/45 (2.22%)  1
Skin and subcutaneous tissue disorders   
Hand Foot Skin Reaction  1  6/45 (13.33%)  6
Vascular disorders   
Hypertension  1  3/45 (6.67%)  3
Deep vein thrombosis  1  1/45 (2.22%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bevacizumab Plus Capecitabine
Affected / at Risk (%) # Events
Total   30/45 (66.67%)    
Blood and lymphatic system disorders   
Anemia  2  13/45 (28.89%)  13
Thrombocytopenia  2  8/45 (17.78%)  8
Leukopenia  2  7/45 (15.56%)  7
Hemorrhage-Nose  2  6/45 (13.33%)  6
Edema-limb  2  5/45 (11.11%)  5
Ear and labyrinth disorders   
Dizziness  2  5/45 (11.11%)  5
Gastrointestinal disorders   
Diarrhea  1  28/45 (62.22%)  28
Nausea  1  21/45 (46.67%)  21
Mucositis  2  16/45 (35.56%)  16
Anorexia  2  15/45 (33.33%)  15
Vomiting  2  9/45 (20.00%)  9
Dehydration  2  7/45 (15.56%)  7
General disorders   
Fatigue  1  30/45 (66.67%)  30
Memory Impairment  2  5/45 (11.11%)  5
Metabolism and nutrition disorders   
Weight Loss  2  5/45 (11.11%)  5
Nervous system disorders   
Neuropathy  2  11/45 (24.44%)  11
Pain-Abdomen  2  10/45 (22.22%)  10
Pain-Head  2  5/45 (11.11%)  5
Renal and urinary disorders   
Proteinuria  2  7/45 (15.56%)  7
Skin and subcutaneous tissue disorders   
Hand Foot Skin Reaction  2  24/45 (53.33%)  24
Dry Skin  2  8/45 (17.78%)  8
Rash  2  7/45 (15.56%)  7
Vascular disorders   
Hypertension  2  10/45 (22.22%)  10
Indicates events were collected by systematic assessment
1
Term from vocabulary, Criteria for Adverse
2
Term from vocabulary, CTCAE (Unspecified)
This was a small study with only 45 participants who received study treatment. With such a small sample size the study does not have the statistical power to make categorical assessments or statements.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Arash Naeim
Organization: Translational Research in Oncology
Phone: 310 267-6810
EMail: anaeim@mednet.ucla.edu
Layout table for additonal information
Responsible Party: Translational Oncology Research International
ClinicalTrials.gov Identifier: NCT00203411     History of Changes
Obsolete Identifiers: NCT00217685
Other Study ID Numbers: TORI GI-04
First Submitted: September 13, 2005
First Posted: September 20, 2005
Results First Submitted: February 10, 2016
Results First Posted: February 6, 2017
Last Update Posted: February 6, 2017